Project Manager – Europe

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects
• Ensure compliance with study budgets, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements
• Serve as primary contact for sponsors, vendors and internal teams throughout studies
• Coordinate tasks and deadlines across departments
• Oversee project coordinators, SSU team members, RDA and RAC resources and prioritize site activation activities
• Coordinate vendor supplies and services with site activation timelines
• Escalate risks to site activation timelines to Project Manager II
• Manage sponsor and stakeholder needs and expectations
• Plan project activities and resources
• Manage quality of assigned work and deliverables
• Provide project status updates to internal and external stakeholders
• Reconcile study trackers and analyze discrepancies between planned and actual results
• Participate in corrective actions, change control and risk management
• Review and assist with drafting project operational plans, processes and manuals
• Ensure study documents and project deliverables meet applicable country requirements
• Oversee site selection and site qualification activities
• Monitor patient recruitment and subject status and follow up with sites on recruitment strategies
• Participate in Investigator’s Meetings
• Oversee central ethics and regulatory submissions with Regulatory Affairs
• Ensure collection and maintenance of essential site documents
• Assist with Trial Master File quality reviews and audits
• Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues
• Track site qualification, initiation, routine and close-out visits, training, monitoring reports, follow-up letters and site issue escalations
• Maintain the project-specific training matrix and confirm team training before study tasks
• Support sites with investigational product, study supplies, equipment and safety lab kits
• Work with Data Management to ensure CRF compliance, query resolution and data review through database lock
• Provide technical, therapeutic and project management expertise in training and process improvement

• B.Sc. in a related field of study to clinical research
• At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry
• At least 2 years of experience coordinating activities related to clinical trial management
• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of Microsoft Office suite
• Excellent oral and written skills in English; French is an asset
• Excellent communication skills
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Experience managing small to medium projects using a disciplined approach to project management
• Demonstrated ability to establish and deliver resource-based project plans
• Excellent people management skills; experience working with and managing teams in a matrix environment
• Must be legally able to work in the EU

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development
• Attractive advancement opportunities
• Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request